Raise
Medical Writer (Clinical Evaluation Specialist) - 177182
Raise, Sunnyvale, California, United States,
We’re Hiring!
Our key client in clinical robotics is looking for additional members for their team. We have a
Medical Writer (Clinical Evaluation Specialist)
on the team.
Pay Rate:
$70.00/hour on W2Work Type:
Hybrid – Onsite 2 days a weekLocation:
Sunnyvale, CA 94086Duration:
3-month contract (with possible extension)
Job Overview:This position reports to the Manager, Medical Science, and requires a strong candidate with experience in medical writing of clinical regulatory documents.The position will mainly focus on supporting the in-house team with the Clinical Evaluation Reports (CERs), with the potential for future additional responsibility for developing other clinical evidence documents.The purpose of this job is to support clinical evaluation reports (CERs) per Medical Device Regulation (MDR), to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.Key Responsibilities:Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports [CER].Acquire knowledge of therapeutic areas, literature review processes, and the ability to keep abreast of current literature.Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.Work with the clinical librarian to help with conducting literature searches on products/product families.Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures.Support the internal team members by adhering to CER timelines and providing data on time to support global Regulatory activities.Interacting with internal teams to understand the plan and strategy for developing the Clinical evaluation reports for new and existing products.Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities.May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations, and posters based on the company’s clinical trials.May author Protocols and/or routine Clinical Study Progress Reports.Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines)Qualifications:MD, PhD, or M.S. degree in a scientific field is desired.Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.Must have a minimum of 2-4 years of medical writing experience.Minimum of 0-2 years of experience in clinical evaluation report writing in the medical device industry is preferred.Strong experience in conducting literature searches, reviews, and appraisal of scientific data.Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing.Demonstrated effective scientific writing skills.Excellent critical and analytical thinking skills.Must have a high level of attention to detail and accuracy.Must be able to work effectively with internal team members.Must be able to manage multiple projects across numerous surgical disciplines.Strong communication, presentation, and interpersonal skills with high attention to detail and organization.Strong experience in protocol development and writing clinical sections for regulatory submission.Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)Consistently shows dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary.Raise PBC is committed to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religious creed, national origin, ancestry, age, disability, genetics, gender identity, veterans' status, sexual orientation, or any other characteristic protected by law. Raise PBC is an equal-opportunity employer encouraging diversity in the workplace.
Our key client in clinical robotics is looking for additional members for their team. We have a
Medical Writer (Clinical Evaluation Specialist)
on the team.
Pay Rate:
$70.00/hour on W2Work Type:
Hybrid – Onsite 2 days a weekLocation:
Sunnyvale, CA 94086Duration:
3-month contract (with possible extension)
Job Overview:This position reports to the Manager, Medical Science, and requires a strong candidate with experience in medical writing of clinical regulatory documents.The position will mainly focus on supporting the in-house team with the Clinical Evaluation Reports (CERs), with the potential for future additional responsibility for developing other clinical evidence documents.The purpose of this job is to support clinical evaluation reports (CERs) per Medical Device Regulation (MDR), to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.Key Responsibilities:Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports [CER].Acquire knowledge of therapeutic areas, literature review processes, and the ability to keep abreast of current literature.Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies.Work with the clinical librarian to help with conducting literature searches on products/product families.Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures.Support the internal team members by adhering to CER timelines and providing data on time to support global Regulatory activities.Interacting with internal teams to understand the plan and strategy for developing the Clinical evaluation reports for new and existing products.Conduct proofreading, editing, document formatting, review comment integration, and document completion/approval activities.May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations, and posters based on the company’s clinical trials.May author Protocols and/or routine Clinical Study Progress Reports.Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines)Qualifications:MD, PhD, or M.S. degree in a scientific field is desired.Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports.Must have a minimum of 2-4 years of medical writing experience.Minimum of 0-2 years of experience in clinical evaluation report writing in the medical device industry is preferred.Strong experience in conducting literature searches, reviews, and appraisal of scientific data.Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing.Demonstrated effective scientific writing skills.Excellent critical and analytical thinking skills.Must have a high level of attention to detail and accuracy.Must be able to work effectively with internal team members.Must be able to manage multiple projects across numerous surgical disciplines.Strong communication, presentation, and interpersonal skills with high attention to detail and organization.Strong experience in protocol development and writing clinical sections for regulatory submission.Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)Consistently shows dedication or strong work ethic to help meet aggressive timelines or multiple projects when necessary.Raise PBC is committed to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religious creed, national origin, ancestry, age, disability, genetics, gender identity, veterans' status, sexual orientation, or any other characteristic protected by law. Raise PBC is an equal-opportunity employer encouraging diversity in the workplace.